The Effect of Stress on the Residual Gastric Volume

NCT ID: NCT05406245

Last Updated: 2022-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-12-15

Brief Summary

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In our institution, many patients undergo staged bilateral total knee arthroplasty at weekly intervals, and most of the patients are older adults with degenerative arthritis. As recommended, the older adult patients who undergoing total knee arthroplasty drink carbohydrate-containing fluid (400 ml) 2 hours prior to surgery. In this type of surgery, there are additional points to consider when applying the fasting guidelines. This is because, in addition to the factor of advanced age, which can affect gastric emptying time, the patient's physical, medical, and psychological conditions at the first and the second operation may be different. For example, the effect of the acute pain that occurs after the first total knee arthroplasty and subsequent opioids administered on gastric motility cannot be ignored. However, to date, there have been no studies examining the association of stress (emotional and surgical) and residual gastric volume of older adult patients with staged bilateral total knee arthroplasty and whether there is a difference according to the stage when carbohydrate-containing fluid is ingested.

In the present study, the investigators will evaluate the effect of emotional stress, surgical stress, pain, and the use of opioids on the residual gastric volume in older adults undergoing staged-bilateral total knee arthroplasty.

Detailed Description

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Conditions

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Arthritis Knee

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group C

Patients drank carbohydrate fluid 2 hours prior to surgery.

Carbohydrate drinking

Intervention Type DIETARY_SUPPLEMENT

Administration of carbohydrate fluid

Interventions

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Carbohydrate drinking

Administration of carbohydrate fluid

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for staged bilateral total knee arthroplasty aged ≥ 65
* American Society of Anesthesiologists physical status classification 1, 2, and 3
* Body mass index \< 35 kg/cm2
* Patients administered carbohydrate-containing fluid 2 hours prior to surgery

Exclusion Criteria

* Previous surgery of the upper gastrointestinal tract
* Achalasia
* Diabetes
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Seok Na

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyo-Seok Na, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyun-Jung Shin, MD., PhD.

Role: CONTACT

82317877508

Facility Contacts

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Hyun-Jung Shin, MD., PhD.

Role: primary

Other Identifiers

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B-2206-761-301

Identifier Type: -

Identifier Source: org_study_id

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